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INOVEE: INtensity of OVarian Stimualtion and Euploid Embryos

Sponsor
Fundación Santiago Dexeus Font (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06154083
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
29
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized trial was designed as a no-inferiority trial aiming to evaluate if the intensity of stimulation (a milder vs a more intense approach) may have an impact on the number of euploid embryos and the morpho kinetic parameters in advanced age women undergoing PGT-A with a PPOS protocol.

Condition or Disease Intervention/Treatment Phase
  • Drug: Follitropin-delta (Rekovelle) 20 mcg/day from D1
  • Drug: Follitropin-delta (Rekovelle) 15 mcg/day from D1
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Impact of Ovarian Stimulation Intensity on Embryo Euploidy in Advanced Age Women
Anticipated Study Start Date :
Dec 15, 2023
Anticipated Primary Completion Date :
Dec 15, 2025
Anticipated Study Completion Date :
May 15, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Follitropin-delta 20 mcg/day from D1

Drug: Follitropin-delta (Rekovelle) 20 mcg/day from D1
On day 2 or 3 of the menstrual cycle, daily injections of 20 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
Active Comparator: Follitropin-delta 15 mcg/day from D1

Drug: Follitropin-delta (Rekovelle) 15 mcg/day from D1
On day 2 or 3 of the menstrual cycle, daily injections of 15 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls and blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.

Outcome Measures

Primary Outcome Measures

  1. Number of euploid embryos [Trough study completion, an average of 20-30 days.]

    Number of euploid embryos

Secondary Outcome Measures

  1. Gonadotropin dose [Up to oocyte pickup, an average of 10-20 days]

    Total gonadotropin dose used

  2. Length of stimulation [Up to oocyte pickup, an average of 10-20 days]

    Days of stimulation

  3. Estradiol [Up to oocyte pickup, an average of 10-20 days]

    Estradiol level

  4. Progesterone [Up to oocyte pickup, an average of 10-20 days]

    Progesterone level

  5. LH [Up to oocyte pickup, an average of 10-20 days]

    LH level

  6. Follicular Output RaTe (FORT) [Day one of stimulation. 1 Day]

    ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation

  7. Cycle cancelation rate [Up to oocyte pickup, an average of 10-20 days]

    Cycle cancelation rate

  8. Fertilization rate [Up to one day after oocyte pickup, an average of 10-20 days]

    Fertilization rate

  9. Time of appearance of the 2nd polar body (tPB2) [Up to one day after oocyte pickup, an average of 10-20 days]

    Time of appearance of the 2nd polar body (tPB2)

  10. Time of pronuclei disappearance (tPNf) [Up to one day after oocyte pickup, an average of 10-20 days]

  11. Time of division from 2 to 8 cells [Until 1, or 4 days after insemination]

  12. Time of compactation (tSC) [Until 3, or 4 days after insemination]

  13. Time of morula (tM) [Until 4 or 7 days after insemination]

  14. Time of cavitation (tSB) [Until 4 or 7 days after insemination]

  15. Time of full blastulation (tB) [Until 4 or 7 days after insemination]

  16. Total number of day 5 blastocysts [Until 5, 6 or 7 days after insemination]

  17. Total number of good quality blastocysts [Until 5, 6 or 7 days after insemination]

  18. Total number of embryos [Until 5, 6 or 7 days after insemination]

  19. Blastocyst formation rate [Until 5, 6 or 7 days after insemination]

    proportion of 2PN zygotes that reach the blastocyst stage

  20. Number of embryos cryopreserved [Until 5, 6 or 7 days after insemination]

  21. Embryo stage [Until 5, 6 or 7 days after insemination]

  22. Clinical pregnancy rate [5-6 weeks after transfer]

    defined as the visualization of one or more gestational sacs

  23. Ongoing pregnancy rate [8-10 weeks after transfer]

    defined as a viable intrauterine pregnancy

Eligibility Criteria

Criteria

Ages Eligible for Study:
38 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Infertile patients with indication for IVF

  • Undergoing preimplantation genetic screening cycles

  • AMH >= 1.5 ng/ml and < 3.5 ng/ml (AMH result of up to one year will be valid)

  • BMI 18.5 - 30 Kg/m2

Exclusion Criteria:

  • Severe male factor requiring TESE (testicular sperm extraction)

  • AMH < 1.5 ng/ml or >= 3.5 ng/ml

  • Administration of any other drug potentially interfering with the treatment

  • Contraindication for hormonal treatment

  • Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).

  • Monogenic disease to be detected with PGT-M

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Quiron Dexeus Barcelona Spain 08028

Sponsors and Collaborators

  • Fundación Santiago Dexeus Font

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Fundación Santiago Dexeus Font
ClinicalTrials.gov Identifier:
NCT06154083
Other Study ID Numbers:
  • FSD-INO-2023-14
  • 2023-507028-22
First Posted:
Dec 1, 2023
Last Update Posted:
Dec 1, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Follicle Stimulating Hormone

Study Results

No Results Posted as of Dec 1, 2023